Clinical Trials Directory

Trials / Completed

CompletedNCT07458178

A New Scoring System to Predict High-Risk Groups in Upper Gastrointestinal Bleeding

A New Scoring System to Predict High-Risk Groups in Upper Gastrointestinal Bleeding and Comparison of the Found Score With Scoring Systems in the Literature

Status
Completed
Phase
Study type
Observational
Enrollment
312 (actual)
Sponsor
Izmir Katip Celebi University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Upper gastrointestinal bleeding (UGIB) remains a common and potentially life-threatening emergency condition requiring early risk stratification to guide clinical management. Although several validated scoring systems such as Rockall, Glasgow-Blatchford Score (GBS), AIMS65, H3B2, ABC, ABL, and Pre-endoscopic Rockall (Pre-RS) are widely used, their discriminative performance for identifying patients at high clinical risk varies across populations. This retrospective, single-center observational study included 312 adult patients admitted to the emergency department between January 2024 and January 2026 with clinical manifestations of UGIB. Patients were categorized into high-risk and low-risk groups based on clinically significant outcomes, including transfusion requirement, endoscopic/radiological/surgical intervention, intensive care unit admission, rebleeding, or in-hospital mortality. The primary objective was to develop a novel risk score (HOLD\_B), derived from independent predictors identified through multivariable logistic regression analysis. Receiver Operating Characteristic (ROC) curve analysis was used to determine optimal cut-off values for continuous predictors and to evaluate discriminative performance. The newly developed score was compared with established scoring systems using area under the curve (AUC) analysis and DeLong's test for pairwise comparisons. The study aims to provide a simplified and clinically applicable risk stratification tool for early identification of high-risk UGIB patients in the emergency department setting.

Conditions

Timeline

Start date
2024-01-01
Primary completion
2026-01-01
Completion
2026-01-01
First posted
2026-03-09
Last updated
2026-03-13

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT07458178. Inclusion in this directory is not an endorsement.